AAFP Continues Work to Fix Issues With Diabetic Testing Supplies

As anyone who follows AAFP advocacy efforts knows, the Academy sends a steady flow of letters to CMS commenting on proposed regulations, suggesting fixes to those proposals and, in some cases, pointing out that existing rules are negatively impacting family physicians and their patients.

What's not so common is for the AAFP to receive a letter from CMS(3 page PDF) responding to specific Academy concerns, asking for additional background information and requesting further collaboration.

Such was the case recently when CMS Acting Administrator Andrew Slavitt wrote to AAFP Board Chair Robert Wergin, M.D., of Milford, Neb., about issues related to diabetic testing supplies that the AAFP outlined(3 page PDF) in April.

Slavitt agreed that diabetes is "one of the costliest and deadliest of all chronic diseases" and said the AAFP's letter raised concerns.

He reminded Wergin that CMS maintains a "delicate balance" between protecting Medicare from fraud and abuse while at the same time ensuring patients' access to quality care and minimizing physicians' administrative burdens.

Slavitt noted that diabetes testing strips had been identified as an area "vulnerable to fraud" and said that finding prompted CMS to create additional documentation requirements.

The AAFP had suggested that physicians be allowed to write a prescription for diabetic supplies -- including syringes, needles, test strips, lancets and glucose testing machines -- that would be good for the patient's lifetime.

But Slavitt countered that supplies not medically necessary for the use of a blood glucose monitor, such as syringes and needles, were not covered by the Medicare Part B durable medical equipment (DME) benefit. Furthermore, he noted that itemized information was needed to support claims payment.

"However, CMS is always interested in reducing any burden on providers and would like to meet with you to discuss ways to minimize documentation requirements while maintaining the integrity of the Medicare Trust Fund," said Slavitt.

Regarding the AAFP's call for assistance to stop DME suppliers from making unsolicited contact with patients, Slavitt quoted sections of the Social Security Act that detailed when such contact was legal and the consequences for suppliers who violated the regulations.

He asked that the Academy provide specific details to him in writing or report such rule infringement to Medicare for investigation.

In previous correspondence, the AAFP also expressed alarm about the efficacy of "unbranded" diabetes testing supplies now being sold by some equipment suppliers, presumably as a means of increasing profits.

"Under Medicare, suppliers of DME must be accredited and meet quality standards, including the requirement to only furnish products that meet applicable FDA regulations and medical device effectiveness and safety standards," said Slavitt.

He asked the AAFP to report information about specific products that did not meet those regulations directly to the FDA.

Slavitt also addressed the AAFP's questions about the brands of test strips available to Medicare patients via mail order. He cited study results that "showed little change in the top 10 brands furnished to beneficiaries before and after implementation of the mail order program."

Again, Slavitt asked the Academy to provide detailed information directly to the FDA about the efficacy of specific testing strip products.

Lastly, he expressed CMS' desire to work with the AAFP further to reconcile issues outlined in the letter.